The effect of chamomile aromatherapy with and without oxygen on severity of pain, bloating and nausea in women after cesarean section with spinal anesthesia.
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Protocol summary
136 women undergoing cesarean section were randomly assigned to three intervention groups and one control group. The data collection tool was visual analogue scale completed by the researcher 6, 9, 12 hours after cesarean section
136 women undergoing cesarean section were randomly assigned to three intervention groups and one control group. The data collection tool was visual analogue scale completed by the researcher 6, 12, 18 hours after cesarean section
136 women undergoing cesarean section were randomly assigned to three intervention groups and one control group. The data collection tool was visual analogue scale completed by the researcher 6, 912, 1218 hours after cesarean section
136 زن تحت عمل سزارین به صورت تصادفی به سه گروه مداخله و یک گروه کنترل تخصیص می یابند مداخله در بیمارستان امام سجاد شهر یاسوج انجام می شود. ابزار گردآوری داده ها مقیاس آنالوگ بصری است که 6، 9، 12 ساعت بعد از سزارین توسط پژوهشگر تکمیل می گردد.
136 زن تحت عمل سزارین به صورت تصادفی به سه گروه مداخله و یک گروه کنترل تخصیص می یابند مداخله در بیمارستان امام سجاد شهر یاسوج انجام می شود. ابزار گردآوری داده ها مقیاس آنالوگ بصری است که 6، 12، 18 ساعت بعد از سزارین توسط پژوهشگر تکمیل می گردد.
136 زن تحت عمل سزارین به صورت تصادفی به سه گروه مداخله و یک گروه کنترل تخصیص می یابند مداخله در بیمارستان امام سجاد شهر یاسوج انجام می شود. ابزار گردآوری داده ها مقیاس آنالوگ بصری است که 6، 912، 1218 ساعت بعد از سزارین توسط پژوهشگر تکمیل می گردد.
General information
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136
136
2019-10-12, 1398/07/20
2020-01-05, 1398/10/15
20192020-1001-1205 00:00:00
2019-11-21, 1398/08/30
2020-03-18, 1398/12/28
20192020-1103-2118 00:00:00
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2020-01-05, 1398/10/15
2020-01-05 00:00:00
empty
2020-03-18, 1398/12/28
2020-03-18 00:00:00
empty
2020-03-19, 1398/12/29
2020-03-19 00:00:00
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At the beginning of the study, changes were made in the intervention times and measurement times. These changes were recorded
At the beginning of the study, changes were made in the intervention times and measurement times. These changes were recorded
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در زمان مطالعه در زمان های مداخله و زمان های اندازه گیری تغییراتی ایجاد شده بود ثبت شد
در زمان مطالعه در زمان های مداخله و زمان های اندازه گیری تغییراتی ایجاد شده بود ثبت شد
Health conditions studied
#1
cesarean section
pain, nausea and distention of women in post Cesarean section with spinal anesthesia
cesareanpain, nausea and distention of women in post Cesarean section with spinal anesthesia
عمل جراحی سزارین
درد، تهوع و نفخ بعد از سزارین با بیحسی نخاعی
عمل جراحیدرد، تهوع و نفخ بعد از سزارین با بیحسی نخاعی
Primary outcomes
#1
6 hours after cesarean section, 9 hours after cesarean section, 12 hours after cesarean section
6 hours after cesarean section, 12 hours after cesarean section, 18hours after cesarean section
6 hours after cesarean section, 9 hours after cesarean section, 12 hours after cesarean section, 18hours after cesarean section
6 ساعت پس از عمل سزارین، 9ساعت پس از عمل سزارین، 12ساعت پس از عمل سزارین
6 ساعت پس از عمل سزارین، 12ساعت پس از عمل سزارین، 18ساعت پس از عمل سزارین
6 ساعت پس از عمل سزارین، 9ساعت پس از عمل سزارین، 12ساعت پس از عمل سزارین، 18ساعت پس از عمل سزارین
#2
6 hours after cesarean section, 9 hours after cesarean section, 12 hours after cesarean section
6 hours after cesarean section, 12 hours after cesarean section, 18 hours after cesarean section
6 hours after cesarean section, 9 hours after cesarean section, 12 hours after cesarean section, 18 hours after cesarean section
6 ساعت پس از عمل سزارین، 9ساعت پس از عمل سزارین، 12ساعت پس از عمل سزارین
6 ساعت پس از عمل سزارین، 12ساعت پس از عمل سزارین، 18ساعت پس از عمل سزارین
6 ساعت پس از عمل سزارین، 9ساعت پس از عمل سزارین، 12ساعت پس از عمل سزارین، 18ساعت پس از عمل سزارین
#3
6 hours after cesarean section, 9 hours after cesarean section, 12 hours after cesarean section
6 hours after cesarean section, 12 hours after cesarean section, 18 hours after cesarean section
6 hours after cesarean section, 9 hours after cesarean section, 12 hours after cesarean section, 18 hours after cesarean section
6 ساعت پس از عمل سزارین، 9ساعت پس از عمل سزارین، 12ساعت پس از عمل سزارین
6 ساعت پس از عمل سزارین، 12ساعت پس از عمل سزارین، 18ساعت پس از عمل سزارین
6 ساعت پس از عمل سزارین، 9ساعت پس از عمل سزارین، 12ساعت پس از عمل سزارین، 18ساعت پس از عمل سزارین
Intervention groups
#1
Intervention of chamomile aromatherapy with oxygen (chamomile essential oil from Zardband Company) is given to patients about the general purpose of the research and informed consent is obtained from them and their spouse. Training on collecting these samples is required to collect information and a baseline questionnaire including demographic and morphometric information is collected. On the day that is selected as intervention day 1, patients in the intervention group will be rubbed with a patch test on a wrist (patch test) and covered with a cloth for 2 minutes to determine if they are allergic. Delete the study.In this intervention group, a drop of chamomile essential oil plus distilled water is poured into a small nebulizer that attaches to the facial mask and adjusts to 6 liters per minute (28), which is a drop of essential oil when entering the women's ward. Chamomile with distilled water is poured into a small nebulizer attached to the face mask and oxygen is adjusted for 6 liters per minute (delay test) and then half an hour before meals (which begins 8 hours after the diet). For half an hour after meals and one hour after meals, the mask is applied to the patient's face for 5 minutes each time. 5-12 liters per minute with a simple mask can deliver 35-50% oxygen to the patient
Intervention of chamomile aromatherapy with oxygen (chamomile essential oil from Zardband Company) is given to patients about the general purpose of the research and informed consent is obtained from them and their spouse. Training on collecting these samples is required to collect information and a baseline questionnaire including demographic and morphometric information is collected. On the day that is selected as intervention day 1, patients in the intervention group will be rubbed with a patch test on a wrist (patch test) and covered with a cloth for 2 minutes to determine if they are allergic. Delete the study.In this intervention group, a drop of chamomile essential oil plus distilled water is poured into a small nebulizer that attaches to the facial mask and adjusts to 6 liters per minute (28), which is a drop of essential oil when entering the women's ward. Chamomile with distilled water is poured into a small nebulizer attached to the face mask and oxygen is adjusted for 6 liters per minute (delay test(At 6, 6.30 and 7 hours after the operation, the mask is applied to the patient's face for 5 minutes each time. 5-12 liters per minute with a simple mask can deliver 35-50% oxygen to the patient
Intervention of chamomile aromatherapy with oxygen (chamomile essential oil from Zardband Company) is given to patients about the general purpose of the research and informed consent is obtained from them and their spouse. Training on collecting these samples is required to collect information and a baseline questionnaire including demographic and morphometric information is collected. On the day that is selected as intervention day 1, patients in the intervention group will be rubbed with a patch test on a wrist (patch test) and covered with a cloth for 2 minutes to determine if they are allergic. Delete the study.In this intervention group, a drop of chamomile essential oil plus distilled water is poured into a small nebulizer that attaches to the facial mask and adjusts to 6 liters per minute (28), which is a drop of essential oil when entering the women's ward. Chamomile with distilled water is poured into a small nebulizer attached to the face mask and oxygen is adjusted for 6 liters per minute (delay test)test(At 6, 6.30 and then half an hour before meals (which begins 87 hours after the diet). For half an hour after meals and one hour after mealsoperation, the mask is applied to the patient's face for 5 minutes each time. 5-12 liters per minute with a simple mask can deliver 35-50% oxygen to the patient
گروه مداخله: مداخله یک آروماتراپی بابونه با اکسیژن ( اسانس بابونه تهیه شده از شرکت زردبند) به بیماران در مورد هدف کلی پژوهش اطلاعاتی داده می شود و رضایت آگاهانه از آنها و همسرشان اخذ می شود. در مورد همکاری این نمونه ها جهت جمع آوری اطلاعات آموزش های لازم داده می شود و پرسشنامه ابتدایی که شامل اطلاعات جمعیت شناختی و مرفومتریک می باشد جمع آوری می شود. در روزی که به عنوان روز مداخله یک انتخاب می شود، بیماران گروه مداخله یک جهت تشخیص حساسیت، یک قطره اسانس بابونه روی مچ دست آنها مالیده می شود (patch test) و به مدت 2 دقیقه با لباس پوشانده می شود تا در صورت حساسیت از مطالعه حذف شود. و در این گروه مداخله یک قطره از اسانس بابونه به همراه آب مقطر در یک نبولایزر کوچک که به ماسک ساده صورت وصل می شود ریخته شده واکسیژن 6 لیتر در دقیقه تنظیم می گردد(28) که در زمان ورود به بخش زنان یک قطره از اسانس بابونه به همراه آب مقطر در یک نبولایزر کوچک که به ماسک صورت وصل شده ریخته می شود و اکسیژن 6 لیتر در دقیقه تنظیم میگردد(تست تاخیری) و سپس نیم ساعت قبل از شروع غذا (که 8 ساعت بعد از عمل رژیم غذایی شروع می شود) ونیم ساعت پس از غذا و یک ساعت پس از غذا هر بار به مدت 5 دقیقه ماسک روی صورت بیمار قرار می گیرد. که 12- 5 لیتر در دقیقه با ماسک ساده می تواند 50-35 درصد اکسیژن به بیمار برساند
گروه مداخله: مداخله یک آروماتراپی بابونه با اکسیژن ( اسانس بابونه تهیه شده از شرکت زردبند) به بیماران در مورد هدف کلی پژوهش اطلاعاتی داده می شود و رضایت آگاهانه از آنها و همسرشان اخذ می شود. در مورد همکاری این نمونه ها جهت جمع آوری اطلاعات آموزش های لازم داده می شود و پرسشنامه ابتدایی که شامل اطلاعات جمعیت شناختی و مرفومتریک می باشد جمع آوری می شود. در روزی که به عنوان روز مداخله یک انتخاب می شود، بیماران گروه مداخله یک جهت تشخیص حساسیت، یک قطره اسانس بابونه روی مچ دست آنها مالیده می شود (patch test) و به مدت 2 دقیقه با لباس پوشانده می شود تا در صورت حساسیت از مطالعه حذف شود. و در این گروه مداخله یک قطره از اسانس بابونه به همراه آب مقطر در یک نبولایزر کوچک که به ماسک ساده صورت وصل می شود ریخته شده واکسیژن 6 لیتر در دقیقه تنظیم می گردد(28) که در زمان ورود به بخش زنان یک قطره از اسانس بابونه به همراه آب مقطر در یک نبولایزر کوچک که به ماسک صورت وصل شده ریخته می شود و اکسیژن 6 لیتر در دقیقه تنظیم میگردد(تست تاخیری) و سپس ساعات 6، 6.30 و 7 هر بار به مدت 5 دقیقه ماسک روی صورت بیمار قرار می گیرد. که 12- 5 لیتر در دقیقه با ماسک ساده می تواند 50-35 درصد اکسیژن به بیمار برساند
گروه مداخله: مداخله یک آروماتراپی بابونه با اکسیژن ( اسانس بابونه تهیه شده از شرکت زردبند) به بیماران در مورد هدف کلی پژوهش اطلاعاتی داده می شود و رضایت آگاهانه از آنها و همسرشان اخذ می شود. در مورد همکاری این نمونه ها جهت جمع آوری اطلاعات آموزش های لازم داده می شود و پرسشنامه ابتدایی که شامل اطلاعات جمعیت شناختی و مرفومتریک می باشد جمع آوری می شود. در روزی که به عنوان روز مداخله یک انتخاب می شود، بیماران گروه مداخله یک جهت تشخیص حساسیت، یک قطره اسانس بابونه روی مچ دست آنها مالیده می شود (patch test) و به مدت 2 دقیقه با لباس پوشانده می شود تا در صورت حساسیت از مطالعه حذف شود. و در این گروه مداخله یک قطره از اسانس بابونه به همراه آب مقطر در یک نبولایزر کوچک که به ماسک ساده صورت وصل می شود ریخته شده واکسیژن 6 لیتر در دقیقه تنظیم می گردد(28) که در زمان ورود به بخش زنان یک قطره از اسانس بابونه به همراه آب مقطر در یک نبولایزر کوچک که به ماسک صورت وصل شده ریخته می شود و اکسیژن 6 لیتر در دقیقه تنظیم میگردد(تست تاخیری) و سپس نیم ساعت قبل از شروع غذا (که 8 ساعت بعد از عمل رژیم غذایی شروع می شود) ونیم ساعت پس از غذاساعات 6، 6.30 و یک ساعت پس از غذا7 هر بار به مدت 5 دقیقه ماسک روی صورت بیمار قرار می گیرد. که 12- 5 لیتر در دقیقه با ماسک ساده می تواند 50-35 درصد اکسیژن به بیمار برساند
Recruitment centers
#1
Name of recruitment center - English: Imam Sajjad Yasuj Hospital
Name of recruitment center - Persian: بیمارستان امام سجاد یاسوج
Full name of responsible person - English: Nazafarin Hosseini
Full name of responsible person - Persian: نازآفرین حسینی
Street address - English: nursing school , Dr. Shahid Jalil street, Yasouj , Iran
Street address - Persian: ایران ، یاسوج ، خیابان دکتر شهید جلیل، دانشکده پرستاری
City - English: Yasuj
City - Persian: یاسوج
Province: Kohgilouyeh-va-Boyrahmad
Country: Iran (Islamic Republic of)
Postal code: 7591994799
Phone: +98 74 3323 5140
Fax:
Email: hosseinichenar@yahoo.com
Web page address:
Name of recruitment center - English: Imam Sajjad Yasuj Hospital
Name of recruitment center - Persian: بیمارستان امام سجاد یاسوج
Full name of responsible person - English: Nazafarin Hosseini
Full name of responsible person - Persian: نازآفرین حسینی
Street address - English: Nursing school , Dr. Shahid Jalil street, Yasouj , Iran
Street address - Persian: ایران ، یاسوج ، خیابان دکتر شهید جلیل، دانشکده پرستاری
City - English: Yasuj
City - Persian: یاسوج
Province: Kohgilouyeh-va-Boyrahmad
Country: Iran (Islamic Republic of)
Postal code: 7591994799
Phone: +98 74 3323 5140
Fax:
Email: Hosseinichenar@yahoo.com
Web page address: https://fa.irct.ir/user/trial/66188
Name of recruitment center - English: Imam Sajjad Yasuj Hospital Name of recruitment center - Persian: بیمارستان امام سجاد یاسوج Full name of responsible person - English: Nazafarin Hosseini Full name of responsible person - Persian: نازآفرین حسینی Street address - English: nursingNursing school , Dr. Shahid Jalil street, Yasouj , Iran Street address - Persian: ایران ، یاسوج ، خیابان دکتر شهید جلیل، دانشکده پرستاری City - English: Yasuj City - Persian: یاسوج Province: Kohgilouyeh-va-Boyrahmad Country: Iran (Islamic Republic of) Postal code: 7591994799 Phone: +98 74 3323 5140 Fax: Email: hosseinichenarHosseinichenar@yahoo.com Web page address: https://fa.irct.ir/user/trial/66188
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Vice-chancellor of Research, Dr. Hossein Mari Oryad
Full name of responsible person - Persian: معاون پژوهش و فناوری دانشگاه، دکتر حسین ماری اریاد
Street address - English: Vice chancellor of Research and Technology, Yasuj University of Medical Sciences, Shahid Motahari Blvd., Yasuj , Iran
Street address - Persian: ایران ، یاسوج ،بلوار شهیدمطهری - دانشگاه علوم پزشکی یاسوج - معاونت پژوهشی و فناوری دانشگاه
City - English: Yasuj
City - Persian: یاسوج
Province: Kohgilouyeh-va-Boyrahmad
Country: Iran (Islamic Republic of)
Postal code: 7591741417
Phone: +98 74 3334 6078
Fax:
Email: oryadhsn@gmail.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Vice-chancellor of Research, Dr. Hossein Mari Oryad
Full name of responsible person - Persian: معاون پژوهش و فناوری دانشگاه، دکتر حسین ماری اریاد
Street address - English: Vice chancellor of Research and Technology, Yasuj University of Medical Sciences, Shahid Motahari Blvd., Yasuj , Iran
Street address - Persian: ایران ، یاسوج ،بلوار شهیدمطهری - دانشگاه علوم پزشکی یاسوج - معاونت پژوهشی و فناوری دانشگاه
City - English: Yasuj
City - Persian: یاسوج
Province: Kohgilouyeh-va-Boyrahmad
Country: Iran (Islamic Republic of)
Postal code: 7591741417
Phone: +98 74 3334 6078
Fax:
Email: Oryadhsn@gmail.com
Web page address: https://fa.irct.ir/user/trial/66188
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Vice-chancellor of Research, Dr. Hossein Mari Oryad Full name of responsible person - Persian: معاون پژوهش و فناوری دانشگاه، دکتر حسین ماری اریاد Street address - English: Vice chancellor of Research and Technology, Yasuj University of Medical Sciences, Shahid Motahari Blvd., Yasuj , Iran Street address - Persian: ایران ، یاسوج ،بلوار شهیدمطهری - دانشگاه علوم پزشکی یاسوج - معاونت پژوهشی و فناوری دانشگاه City - English: Yasuj City - Persian: یاسوج Province: Kohgilouyeh-va-Boyrahmad Country: Iran (Islamic Republic of) Postal code: 7591741417 Phone: +98 74 3334 6078 Fax: Email: oryadhsnOryadhsn@gmail.com Web page address: https://fa.irct.ir/user/trial/66188
Person responsible for general inquiries
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr. Nazafarin Hosseini
Full name of responsible person - Persian: دکتر نازآفرین حسینی
Position - English: PhD in Nursing
Position - Persian: دکترای تخصصی پرستاری
Latest degree: phd
Area of specialty/work: 27
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Hazrat Zaynab nursing school . Dr. shahid jalil Street, Yasuj , Iran
Street address - Persian: ایران ، یاسوج ، خیابان شهید دکتر جلیل ، دانشکده پرستاری حضرت زینب (س)
City - English: Yasuj
City - Persian: یاسوج
Province: Kohgilouyeh-va-Boyrahmad
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 7591994799
Phone: 0098 33235140
Mobile: +98 913 329 9427
Fax:
Email: Hosseinichenar@yahoo.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr. Nazafarin Hosseini
Full name of responsible person - Persian: دکتر نازآفرین حسینی
Position - English: PhD in Nursing
Position - Persian: دکترای تخصصی پرستاری
Latest degree: phd
Area of specialty/work: 27
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Hazrat Zaynab nursing school . Dr. shahid jalil Street, Yasuj , Iran
Street address - Persian: ایران ، یاسوج ، خیابان شهید دکتر جلیل ، دانشکده پرستاری حضرت زینب (س)
City - English: Yasuj
City - Persian: یاسوج
Province: Kohgilouyeh-va-Boyrahmad
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 7591994799
Phone: 0098 33235140
Mobile: +98 913 329 9427
Fax:
Email: Hosseinichenar@yahoo.com
Web page address: https://fa.irct.ir/user/trial/66188
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Dr. Nazafarin Hosseini Full name of responsible person - Persian: دکتر نازآفرین حسینی Position - English: PhD in Nursing Position - Persian: دکترای تخصصی پرستاری Latest degree: phd Area of specialty/work: 27 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Hazrat Zaynab nursing school . Dr. shahid jalil Street, Yasuj , Iran Street address - Persian: ایران ، یاسوج ، خیابان شهید دکتر جلیل ، دانشکده پرستاری حضرت زینب (س) City - English: Yasuj City - Persian: یاسوج Province: Kohgilouyeh-va-Boyrahmad Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 7591994799 Phone: 0098 33235140 Mobile: +98 913 329 9427 Fax: Email: Hosseinichenar@yahoo.com Web page address: https://fa.irct.ir/user/trial/66188
Person responsible for scientific inquiries
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr. Nazafarin Hosseini
Full name of responsible person - Persian: دکتر نازآفرین حسینی
Position - English: Associate Professor
Position - Persian: استادیار
Latest degree: phd
Area of specialty/work: 27
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Hazrat Zaynab Nursing School. Dr. shahid jalil Street, Yasuj , Iran
Street address - Persian: ایران ، یاسوج ، خیابان شهید دکتر جلیل ، دانشکده پرستاری حضرت زینب (س)
City - English: Yasuj
City - Persian: یاسوج
Province: Kohgilouyeh-va-Boyrahmad
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 7591994799
Phone: +98 74 3323 5140
Mobile: +98 913 329 9427
Fax:
Email: Hosseinichenar@yahoo.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr. Nazafarin Hosseini
Full name of responsible person - Persian: دکتر نازآفرین حسینی
Position - English: Associate Professor
Position - Persian: دانشیار
Latest degree: phd
Area of specialty/work: 27
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Hazrat Zaynab Nursing School. Dr. shahid jalil Street, Yasuj , Iran
Street address - Persian: ایران ، یاسوج ، خیابان شهید دکتر جلیل ، دانشکده پرستاری حضرت زینب (س)
City - English: Yasuj
City - Persian: یاسوج
Province: Kohgilouyeh-va-Boyrahmad
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 7591994799
Phone: +98 74 3323 5140
Mobile: +98 913 329 9427
Fax:
Email: Hosseinichenar@yahoo.com
Web page address: https://fa.irct.ir/user/trial/66188
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Dr. Nazafarin Hosseini Full name of responsible person - Persian: دکتر نازآفرین حسینی Position - English: Associate Professor Position - Persian: استادیاردانشیار Latest degree: phd Area of specialty/work: 27 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Hazrat Zaynab Nursing School. Dr. shahid jalil Street, Yasuj , Iran Street address - Persian: ایران ، یاسوج ، خیابان شهید دکتر جلیل ، دانشکده پرستاری حضرت زینب (س) City - English: Yasuj City - Persian: یاسوج Province: Kohgilouyeh-va-Boyrahmad Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 7591994799 Phone: +98 74 3323 5140 Mobile: +98 913 329 9427 Fax: Email: Hosseinichenar@yahoo.com Web page address: https://fa.irct.ir/user/trial/66188
Person responsible for updating data
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Hajar Zamani Habibabad
Full name of responsible person - Persian: هاجر زمانی حبیب آباد
Position - English: Nurse
Position - Persian: پرستار
Latest degree: bachelor
Area of specialty/work: 27
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Hazrat Zaynab Nursing School . Dr. shahid jalil Street, Yasuj , Iran
Street address - Persian: ایران ،یاسوج ،خیابان شهید دکتر جلیل، داشکده پرستاری حضرت زینب (س)
City - English: Yasuj
City - Persian: یاسوج
Province: Kohgilouyeh-va-Boyrahmad
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 7591994799
Phone: +98 74 3323 5140
Mobile: +98 917 743 9351
Fax:
Email: Zamani95@gmail.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Hajar Zamani Habibabad
Full name of responsible person - Persian: هاجر زمانی حبیب آباد
Position - English: Nurse
Position - Persian: پرستار
Latest degree: bachelor
Area of specialty/work: 27
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Hazrat Zaynab Nursing School . Dr. shahid jalil Street, Yasuj , Iran
Street address - Persian: ایران ،یاسوج ،خیابان شهید دکتر جلیل، داشکده پرستاری حضرت زینب (س)
City - English: Yasuj
City - Persian: یاسوج
Province: Kohgilouyeh-va-Boyrahmad
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 7591994799
Phone: +98 74 3323 5140
Mobile: +98 917 743 9351
Fax:
Email: Zamani95@gmail.com
Web page address: https://fa.irct.ir/user/trial/66188
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Hajar Zamani Habibabad Full name of responsible person - Persian: هاجر زمانی حبیب آباد Position - English: Nurse Position - Persian: پرستار Latest degree: bachelor Area of specialty/work: 27 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Hazrat Zaynab Nursing School . Dr. shahid jalil Street, Yasuj , Iran Street address - Persian: ایران ،یاسوج ،خیابان شهید دکتر جلیل، داشکده پرستاری حضرت زینب (س) City - English: Yasuj City - Persian: یاسوج Province: Kohgilouyeh-va-Boyrahmad Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 7591994799 Phone: +98 74 3323 5140 Mobile: +98 917 743 9351 Fax: Email: Zamani95@gmail.com Web page address: https://fa.irct.ir/user/trial/66188
Sharing plan
undecided
no
undecidedno
Protocol summary
Study aim
The effect of chamomile aromatherapy with and without oxygen on the severity of pain, bloating and nausea in women after cesarean section with spinal anesthesia
Design
The study was a clinical trial with control group performed on 136 women who underwent cesarean section and randomly assigned to 3 intervention groups and one control group.
Settings and conduct
136 women undergoing cesarean section were randomly assigned to three intervention groups and one control group. The data collection tool was visual analogue scale completed by the researcher 6, 12, 18 hours after cesarean section
Participants/Inclusion and exclusion criteria
Inclusion criteria: No history of middle ear disease, no preeclampsia or eclampsia. No smoking or alcohol. No history of chamomile allergies. No history of olfactory problems. Cesarean section should be performed with spinal anesthesia
Change the anesthesia method
Exclusion criteria: Perform cesarean section other than cesarean section. Ill get ill and require more or less than the prescribed oxygen level. Patient needs intensive care
Intervention groups
.Intervention group received chamomile Essence oil with simple mask and small nebulizer, second group oxygenated with simple mask alone, third group received aromatherapy with nebulizer alone and control group received no intervention
Main outcome variables
Pain, bloating, nausea
General information
Reason for update
At the beginning of the study, changes were made in the intervention times and measurement times. These changes were recorded
Acronym
IRCT registration information
IRCT registration number:IRCT20141222020401N7
Registration date:2020-01-05, 1398/10/15
Registration timing:registered_while_recruiting
Last update:2022-10-12, 1401/07/20
Update count:2
Registration date
2020-01-05, 1398/10/15
Registrant information
Name
Nazafarin Hosseini
Name of organization / entity
Yasuj University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 74 3323 5144
Email address
hosseini.nazafarin@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-05, 1398/10/15
Expected recruitment end date
2020-03-18, 1398/12/28
Actual recruitment start date
2020-01-05, 1398/10/15
Actual recruitment end date
2020-03-18, 1398/12/28
Trial completion date
2020-03-19, 1398/12/29
Scientific title
The effect of chamomile aromatherapy with and without oxygen on severity of pain, bloating and nausea in women after cesarean section with spinal anesthesia.
Public title
The effect of chamomile aromatherapy with and without oxygen on severity of pain, bloating and nausea in women after cesarean section with spinal anesthesia.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
no history of middle ear disease, preeclampsia or eclampsia, asthma and other acute and chronic diseases
No smoking or alcohol drinking
No history of allergy to chamomile
No history of olfactory problems
Cesarean section should be performed with spinal anesthesia
Exclusion criteria:
Change the anesthesia method
Other than cesarean section
The patient needs special care
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
136
Actual sample size reached:
136
Randomization (investigator's opinion)
Randomized
Randomization description
The randomized block allocation method with standard 4-person blocks was used and the subjects were divided into 3 intervention groups and one control group, with labels A, B, C, D on four sheets and and oxygen interventions. Aromatherapy, oxygen therapy, aromatherapy and control were also written on four separate sheets, and a colleague who was unaware of this was asked to randomly remove a label for each intervention. In this way we had four random groups and four factorial twenty-four blocks. The size of each block was four and their order was different. Then the blocks were randomly assigned by placement and the patients were sorted. Each block of patients was assigned randomly.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Yasuj University of Medical Sciences
Street address
Assistance of Research and Technology of the University , Yasouj University of Medical Sciences , Shahid Motahari Blvd., Yasuj , Iran
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Approval date
2019-06-25, 1398/04/04
Ethics committee reference number
IR.YUMS.REC.1398.036
Health conditions studied
1
Description of health condition studied
pain, nausea and distention of women in post Cesarean section with spinal anesthesia
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
bloating
Timepoint
6 hours after cesarean section, 12 hours after cesarean section, 18hours after cesarean section
Method of measurement
visual analog scale
2
Description
pain
Timepoint
6 hours after cesarean section, 12 hours after cesarean section, 18 hours after cesarean section
Method of measurement
visual analog scale
3
Description
nausea
Timepoint
6 hours after cesarean section, 12 hours after cesarean section, 18 hours after cesarean section
Method of measurement
visual analog scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention of chamomile aromatherapy with oxygen (chamomile essential oil from Zardband Company) is given to patients about the general purpose of the research and informed consent is obtained from them and their spouse. Training on collecting these samples is required to collect information and a baseline questionnaire including demographic and morphometric information is collected. On the day that is selected as intervention day 1, patients in the intervention group will be rubbed with a patch test on a wrist (patch test) and covered with a cloth for 2 minutes to determine if they are allergic. Delete the study.In this intervention group, a drop of chamomile essential oil plus distilled water is poured into a small nebulizer that attaches to the facial mask and adjusts to 6 liters per minute (28), which is a drop of essential oil when entering the women's ward. Chamomile with distilled water is poured into a small nebulizer attached to the face mask and oxygen is adjusted for 6 liters per minute (delay test(At 6, 6.30 and 7 hours after the operation, the mask is applied to the patient's face for 5 minutes each time. 5-12 liters per minute with a simple mask can deliver 35-50% oxygen to the patient
Category
Prevention
2
Description
Dual Oxygen Intervention alone, Double Intervention at the same time will receive 6 liters of oxygen per minute with simple face mask without aromatherapy chamomile
Category
Prevention
3
Description
Intervention group: Intervention third chamomile aromatherapy alone, Intervention group three will receive chamomile aromatherapy at the same time after sensitization test with oxygen nebulizer
Category
Prevention
4
Description
The control group did not receive oxygen and aromatherapy chamomile.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Sajjad Yasuj Hospital
Full name of responsible person
Nazafarin Hosseini
Street address
Nursing school , Dr. Shahid Jalil street, Yasouj , Iran
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591994799
Phone
+98 74 3323 5140
Email
Hosseinichenar@yahoo.com
Web page address
https://fa.irct.ir/user/trial/66188
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Vice-chancellor of Research, Dr. Hossein Mari Oryad
Street address
Vice chancellor of Research and Technology, Yasuj University of Medical Sciences, Shahid Motahari Blvd., Yasuj , Iran
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 3334 6078
Email
Oryadhsn@gmail.com
Web page address
https://fa.irct.ir/user/trial/66188
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasouj University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Dr. Nazafarin Hosseini
Position
PhD in Nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Hazrat Zaynab nursing school . Dr. shahid jalil Street, Yasuj , Iran